Caregivers-Patients Support Coping With Advanced-Cancer (CASA) Intervention (CASA)

May 14, 2026 updated by: Ponce Medical School Foundation, Inc.
This pilot aims to prepare the PI to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. The catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding areas. The PI's catchment area experiences advanced cancer, and their caregivers are at an increased risk for unmet psychosocial needs; this pre-pilot will allow the PI to focus on this critical gap in equal healthcare. The research goal of this proposal is to refine and pre-pilot an intervention titled Caregivers Patients Support to Cope with Advanced Cancer (CASA), a five-session, 60-minute telehealth series for patient-caregiver dyads. The rationale for this project is that it will lay the groundwork for a Randomized Control Trial (RCT) testing the efficacy of CASA. It will also assess the implementation of an innovative method to deliver the CASA intervention. This study aims to use the collaborative intervention planning framework and ORBIT model to modify and assess the feasibility and preliminary effect of the CASA intervention. The overall impact of this study is to improve access to psychosocial, culturally adapted interventions in the proposed catchment area.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
    • PR
      • Ponce, PR, Puerto Rico, 00717
        • Ponce Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Cancer patients must be stage III and IV solid tumor patients who report distress >4 on the Distress Thermometer
  • Caregivers. Identified caregivers by distressed patients.

Exclusion Criteria:

  • diagnosed with a major disabling medical or psychiatric condition
  • unable to understand the consent procedure, or (3) too ill to participate, all as reported by the participant and/or determined by the investigator's judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Usual Care
Usual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions.
Behavioral: Placebo
Usual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions.
Experimental: CASA
The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be delivered to patients and caregivers. The sessions follow a protocol and will be held weekly or bi-weekly for a total of 5 sessions.
Behavioral: Caregivers-patients support intervention for advanced cancer (CASA)
The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be delivered to patients and caregivers. The sessions follow a protocol and will be held weekly or bi-weekly for a total of 5 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp)
Time Frame: 5 minutes
The Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp) is a 12-item measure of spiritual well-being designed for individuals with cancer and other chronic illnesses. Item development was informed by input from cancer patients, psychotherapists, and religious/spiritual experts. The measure will be administered before and after the intervention.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 5 minutes
The Patient Health Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
5 minutes
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 5 minutes
The Generalized Anxiety Disorder 7-item (GAD-7) is a easy to perform initial screening tool for generalized anxiety disorder
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ponce Medical School Foundation, Inc.

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 19, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2411224820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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